Method for pre-screening and correlation of underlying SCARB1 gene variation to infertility in women and therapeutic use of progestational and other medications in treatment

Abstract

A method of genotyping women experiencing infertility for non-physical reasons in order to identify the presence of the rs4238001 and/or rs10846744 mutation of the SCARB1 gene and, upon identifying the presence of one or both genetic mutations, administering a tailored therapeutic regimen to restore fertility by either one or a combination of 1) mediating the flux of cholesterol resulting from the mutation by therapeutic use of the cholesterol medication probucol and/or other cholesterol altering medications, and/or 2) amplifying the presence of hormone progesterone by therapeutic use of progestational and progestin medications.

I claim: 
     
       1. A method for treating infertility in a human adult female subject comprising the steps of:
 a) confirming that the human adult female subject has been medically diagnosed with infertility, 
 b) performing a medical examination to eliminate physical obstruction as a cause of said diagnosed infertility in said human adult female subject, 
 c) obtaining a whole blood sample from said human adult female subject, 
 d) purifying said whole blood sample, 
 e) isolating nucleic acid from said purified blood sample, 
 f) conducting a genetic gest on said isolated nucleic acid, comprising a microarray assay or a fluorescent allele specific polymerase chain reaction (PCR) based assay that detects the allele for the rs4238001 polymorphism in the SCARB1 gene in said human adult female subject, 
 g) detecting the A allele for rs4238001 in said isolated nucleic acid from said human adult female subject, 
 h) administering a pharmacologically effective regimen of probucol to said human adult female subject to mediate cholesterol in said human adult female subject's bloodstream. 
 
     
     
       2. The method of  claim 1  further comprising periodically administering a comprehensive metabolic profile to correct for one or more of a cholesterol, progesterone, or estrogen hormone imbalance. 
     
     
       3. The method of  claim 1  wherein said genetic test comprises amplification of said isolated nucleic acid. 
     
     
       4. The method of  claim 1  wherein said genetic test further comprises allele specific oligonucleotide probes. 
     
     
       5. The method of  claim 1  wherein said genetic test further comprises direct sequencing. 
     
     
       6. The method of  claim 1  comprising administering a pharmacologically effective regimen of probucol in periodic doses over a period within a range of from 3 to 9 months and monitoring cholesterol in said human adult female subject's bloodstream during the administration period. 
     
     
       7. A method for treating infertility in a human adult female subject comprising the steps of:
 a) selecting a human adult female subject who has been medically diagnosed with infertility, 
 b) obtaining a whole blood sample from said human adult female subject, 
 c) purifying said whole blood sample, 
 c) isolating nucleic acid from said purified blood sample, 
 c) conducting a genetic gest on said isolated nucleic acid, comprising a microarray assay or a fluorescent allele specific polymerase chain reaction (PCR) based assay that detects the allele for the rs4238001 polymorphism in the SCARB1 gene in said human adult female subject, 
 f) detecting the A allele for rs4238001 in said isolated nucleic acid from said human adult female subject, 
 g) administering a pharmacologically effective regimen of probucol to said human adult female subject to mediate cholesterol in said human adult female subject's bloodstream. 
 
     
     
       8. The method of  claim 7 , further comprising increasing progesterone in said human adult female subject. 
     
     
       9. The method of  claim 7 , further comprising a sub step in the genetic test of step e, selected from the group consisting of administering an allele specific oligonucleotide probe or direct sequencing. 
     
     
       10. The method of  claim 7  comprising administering a pharmacologically effective regimen of probucol in periodic doses over a period within a range of from 3 to 9 months and monitoring cholesterol in said human adult female subject's bloodstream during the administration period.